MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number BE-HMOD 30000#BE-QUADROX-ID PÄD.O.FILT.

Device Problem Coagulation in Device or Device Ingredient (1096)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/13/2022

Event Type  malfunction  

Manufacturer Narrative

The event occurred in (b)(6).It was reported that the be-hmod 30000#be-quadrox-id päd.O.Filt.Got clotted on the inlet side and the delta pressure has raised to 197 mmhg in two days.The flows has been reduced drastically even with higher rpm (revolutions per minutes).Subsequently the oxygenator was changed with one from different manufacturer.No harm to any person has been reported.The affected be-hmod 30000#be-quadrox-id päd.O.Filt.Was discarded by the customer therefore a technical investigation in the getinge laboratory is not possible.A picture was provided by the customer on which the clotting on the inlet side is clearly visible.A review of the trend data for similar complaints was performed and no similar complaints were found.Based on these investigation results and the provided information by the customer, the reported failure "clotting inlet side" can be confirmed.The failure mode "clotting inlet side" can be linked to the following most possible root causes according to our risk management file: too low / insufficient anticoagulation, too low at level, effect of heparin is too limited, clotting formation on sharp edges, hemostasis, thrombozytopenia.The device history review (dhr) records were reviewed on 2022-02-18 and according to the final test results, the be-hmod 30000#be-quadrox-id päd.O.Filt.With lot#70138587 and udi#1633373 passed the tests as per specifications.Production related influences are unlikely.In order to avoid re-occurrence of the reported failure, the sales and service unit (ssu) will inform the customer to follow the chapter in the instruction for use instructions for use oxygenator quadrox-id pediatric g-140 version 06 nonus: 5.2 safety instructions for the extracorporeal circulation no anticoagulation or insufficient anticoagulation causes occlusion of the extracorporeal circulation and the patient circuit.This can lead to inadequate patient support, hemolysis or thrombus formation in the patient.Use anticoagulants; e.G., heparin or argatroban.Check the effect of anticoagulants at regular intervals by measuring the act (activated clotting time).Ensure that the act value does not fall below the value which is appropriate for the application.The occurrence rate was calculated for the reported issue and it was determined that this is not a systemic issue.Therefore, no remedial action is required.The occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopulmonary¿s trending program and additional investigations or corrections will be implemented in case of adverse trending.

Event Description

The event occurred in (b)(6).It was reported that the be-hmod 30000#be-quadrox-id päd.O.Filt.Got clotted on the inlet side and the delta pressure has raised to 197 in two days.The flows has been reduced drastically even with higher rpm (revolutions per minutes).Subsequently the oxygenator was changed with one from different manufacturer.No harm to any person has been reported.Complaint id: (b)(4).

• Brand Name: OXYGENATOR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• Manufacturer (Section G): JULIA KAPFENBERGER; neue rottenburger strasse 37; hechingen
• Manufacturer Contact: neue rottenburger strasse 37; hechingen
• MDR Report Key: 13567232
• MDR Text Key: 285928540
• Report Number: 8010762-2022-00056
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K132829
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2022
• Device Model Number: BE-HMOD 30000#BE-QUADROX-ID PÄD.O.FILT.
• Device Catalogue Number: 701047041
• Device Lot Number: 70138587
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/28/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 29 DA
• Patient Sex: Male
• Patient Weight: 4 KG